RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF-T3 (UDI 04953170050992)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170050992), received between Jan 24, 2020 and Apr 29, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGOFIBERSCOPE COATING ON THE CONNECTING TUBE WAS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031938 ↗
• MalfunctionDec 13, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE INSERTION PART WAS PEELING ON THE RHINO-LARYNGOFIBERSCOPE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE RESIN PART OF THE INSERTION TUBE HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15972799 ↗
• MalfunctionSep 14, 2022Material Frayed; Material Frayed

  THE CUSTOMER REPORTED TO OLYMPUS, THE LINING ON THE INSIDE CHANNEL OF THE RHINO-LARYNGOFIBERSCOPE WAS FRAYING/UNRAVELING. THE FRAYED PORTION WAS BLOCKING PART OF THE SCOPE IMAGE. THE ISSUE WAS DETECTED DURING REPROCESSING POST PROCEDURE. THE INTENDED LARYNGOSCOPY WITH INJECTION OF KENALOG PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND CHANNEL NEEDLE. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416913 ↗
• MalfunctionAug 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF AN IMPROPER IMAGE ISSUE OF THE DEVICE. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE IMAGE GUIDE HOB HAD FALLEN OFF. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE IMAGE GUIDE HOB FALLING OFF AS OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322394 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A POLYPECTOMY OF THE LEFT VOCAL CORD USING THE SUBJECT DEVICE, THE PATIENT HAD A NOSE BLEEDING BECAUSE THE FOLDS AND PROTRUSION OF THE SUBJECT DEVICE SUCH AS THE LENS DAMAGED THE PATIENT'S NASAL MUCOSA. THE PATIENT COMPLAINED OF NASAL PAIN AND DISCOMFORT AFTER THE PROCEDURE. THERE WAS NO REPORT OF ADDITIONAL TREATMENT WAS PERFORMED FOR THE PATIENT. THERE WAS NO REPORT OF FURTHER PATIENT INJURY WITH THE EVENT.

  Patient problems: Injury

  MAUDE report 9626653 ↗